Otc - Active Ingredient
Zinc Oxide 15%, Titanium Dioxide 6%, Homosalate 5%, Octisalate 4%
Sunscreen Cream
FDA Label NDC 84938-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Sugar Max Cosmetics Co.,ltd for the product Sunscreen Cream (NDC 84938-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics
Dosage & Administration
Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweatingImmediately after towel drying "at least every 2 hours SunProtection Measures. Spending time in the sun increases yourrisk of skin cancer and early skin aging. To decrease this risk.regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: " limit time in the sun,especially from 10 a.m.-2 p.m."wear long-sleeved children under 6 months:shirts, pants, hats, and sunglassesAsk a doctor.
Inactive Ingredient
Aqua (Water)
Caprylic/Capric Triglyceride
Dimethicone
Glycerin
Sodium Hyaluronate (Hydrolyzed)
Glyceryl Stearate
Cetearyl Alcohol
Ammonium Acryloyldimethyltaurate/VP Copolymer
Phenoxyethanol
Ethylhexyl Glycerin
Hydroxyacetophenone
Aluminum Hydroxide
Stearic Acid
Triethoxycaprylylsilane
Package Label.Principal Display Panel
Label1 (Label1)
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